State's first Research Subject Advocates at UH Medical School

The University of Hawaiʻi John A. Burns School of Medicine has hired two Research Subject Advocates (RSAs) to focus on the protection of human subjects in research. The RSAs will assure that medical research at the UH medical school‘s Clinical Research Center (CRC) is conducted in a relevant, appropriate and safe manner. The research review program — believed to be the first of its kind in the State of Hawaiʻi — is funded through a grant from the National Institutes of Health (NIH) National Center for Research Resources through the Research Centers for Minority Institution Division.

The Clinical Research Center — a joint partnership between UH and Hawaii Pacific Health — has its outpatient clinic located at Kapiʻolani Medical Center for Women and Children, where clinical research studies have been conducted for the past eight years. These studies have addressed a wide range of health challenges including diabetes, heart disease, women‘s health issues, treatment of medically fragile children, drug trials, and testing of traditional Hawaiian medicinal plants, Chinese herbs and other health treatments.

"The protection of human subjects in clinical research is a national concern that prompted support for creation of these new positions for research centers like ours," said UH medical school dean Edwin Cadman, who serves as principal investigator for the NIH grant. "The RSAs will play a key role in strengthening the public‘s participation and trust in clinical research by fostering better communication and coordination among investigators, nurses, and their institutions on issues related to protection of human subjects."

The work of the RSAs could involve assisting investigators in the establishment and development of data and safety monitoring plans for ongoing and new protocols, according to CRC program director, Dr. David Easa. "In this regard," Dr. Easa said, "their work will complement the efforts of the existing Institutional Review Boards (IRBs) at UH and Hawaii Pacific Health — by focusing entirely on the area of human subject research."

One of the RSA positions has been filled by Venkataraman Balaraman, MD, who brings to the position his experience in clinical research and long term membership on both the UH and the Hawaii Pacific Health IRB. The other is filled by Kari Kim, a nationally Certified Institutional Review Board Professional, with 10 years of experience in the areas of human subject protection and research and grants management.